C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinter
FDA device recall Z-0135-2026 · posted 2025-10-10 · Open, Classified
Recall details
- Recalling firm
- Iantrek Inc.
- Reason for recall
- Potential for compromised integrity of the sterile packaging.
- Action taken
- Iantrek notified consignees on 09/06/2025 via email. Consignees were instructed to immediately remove and quarantine all affected units to prevent their use, notify personnel or customers if affected units were forwarded to other facilities. Consignees may also alternatively provide Iantrek with contact information so that they can notify them on the customer's behalf. An Iantrek representative will be contacting each consignee immediately to help facilitate removal, return and replacement of affected units. They will arrange to have replacement product shipped to consignees at no cost.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HMZ
- Quantity affected
- 198
- Distribution
- US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.
- Date initiated
- 2025-09-06
- Date posted
- 2025-10-10
- Location
- Providence, RI
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